BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1172039 · Received September 22, 2008

    Report

    Report Number
    MW5008388
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DEPLOYING THE ANGIOSEAL DEVICE TO CLOSE THE ARTERIOTOMY. THE DEVICE SHEATH BECAME CAUGHT IN THE PATIENT'S LEG TISSUE AND COULD NOT BE REMOVED. SURGICAL INTERVENTION AND AN INCREASED LENGTH OF STAY WAS REQUIRED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL ANGIOSEAL VIP DEVICE MGB ST. JUDE MEDICAL 610130 2152760

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability